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Nevirapine - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for nevirapine?

Nevirapine is the generic ingredient in three branded drugs marketed by Aurobindo, Sandoz Inc, Aurobindo Pharma Ltd, Alvogen Malta, Apotex Inc, Mylan Pharms Inc, Boehringer Ingelheim, Prinston Inc, Cipla Ltd, Cipla, Mylan Labs, Sciegen Pharms Inc, Micro Labs Ltd, Hetero Labs Ltd Iii, Strides Pharma, and Aurobindo Pharma Usa, and is included in twenty-two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty patent family members in twenty-seven countries.

There are twenty drug master file entries for nevirapine. Twenty suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: nevirapine

Tradenames:3
Patents:2
Applicants:16
NDAs:22
Drug Master File Entries: see list20
Suppliers / Packagers: see list20
Bulk Api Vendors: see list77
Clinical Trials: see list47
Patent Applications: see list5,573
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nevirapine at DailyMed

Tentative approvals for NEVIRAPINE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL50MG
► Subscribe► SubscribeTABLET; ORAL200MG
► Subscribe► SubscribeTABLET; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
VIRAMUNE
nevirapine
SUSPENSION;ORAL020933-001Sep 11, 1998RXYesYes► Subscribe► Subscribe
Sciegen Pharms Inc
NEVIRAPINE
nevirapine
TABLET;ORAL203176-001May 22, 2012RXNoNo► Subscribe► Subscribe
Apotex Inc
NEVIRAPINE
nevirapine
TABLET;ORAL203021-001May 22, 2012RXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
NEVIRAPINE
nevirapine
TABLET;ORAL202523-001May 22, 2012RXNoNo► Subscribe► Subscribe
Alvogen Malta
NEVIRAPINE
nevirapine
TABLET, EXTENDED RELEASE;ORAL204621-001Jul 10, 2015RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nevirapine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
VIRAMUNE
nevirapine
SUSPENSION;ORAL020933-001Sep 11, 19985,366,972*PED► Subscribe
Boehringer Ingelheim
VIRAMUNE
nevirapine
TABLET;ORAL020636-001Jun 21, 19965,366,972*PED► Subscribe
Boehringer Ingelheim
VIRAMUNE XR
nevirapine
TABLET, EXTENDED RELEASE;ORAL201152-001Mar 25, 20115,366,972*PED► Subscribe
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International Patent Family for Ingredient: nevirapine

Country Document Number Estimated Expiration
Morocco31430► Subscribe
World Intellectual Property Organization (WIPO)2008154234► Subscribe
EcuadorSP099561► Subscribe
South Africa200904939► Subscribe
Peru03712009► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: NEVIRAPINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/1999Austria► SubscribePRODUCT NAME: NEVIRAPINE; REGISTRATION NO/DATE: EU/1/97/055/001 19980205
C0019France► SubscribePRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGUSTRATION: CH/LI 54 393 19971223
90022Netherlands► SubscribePRODUCT NAME: NEVIRAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; NATL REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION: CH 54393 19971223
C0021Belgium► SubscribePRODUCT NAME: NEVIRAPINE; NAT. REGISTRATION NO/DATE: EU/1/97/055/001 19980205; FIRST REGISTRATION NO/DATE: CH 54393 19971223
C/GB99/020United Kingdom► SubscribePRODUCT NAME: NEVIRAPINE = 11-CYCLOPROPYL-5,11-DIHYDRO-4-METHYL-6H-DIPYRIDO(3,2-B:2',3'-E)(1,4)DIAZEPIN-6-ONE OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF; REGISTERED: CH 54393 19971223; UK EU/1/97/055/001 19980205
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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